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Implementation and Evaluation of Neck-specific Exercises

Primary Purpose

Neck Pain, Whiplash Injuries, Neck Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Implementation strategy - experimental group
Implementation - control group
Sponsored by
Sormland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neck Pain focused on measuring Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria implementation

- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.

Exclusion criteria implementation

- No exclusion criterta

Inclusion criteria to evaluate the effectiveness of neck-specific exercise

  • The physiotherapists will include patients ≥ 18 years with neck pain.
  • Patients are required to have internet access by phone, tablet, or computer
  • Be able to read and understand Swedish

Exclusion criteria:

  • Physiotherapists should exclude patients with "red flags"i.e., symptoms that suggest a serious illness or spinal abnormality.
  • Serious trauma to the neck and no X-ray
  • Preceding neck surgery
  • Osteoporosis
  • Myelopathy
  • History of cancer
  • Unexplained weight loss
  • Present fever, history of infections
  • Constant and progressive non-mechanical pain
  • Insidious progression of pain
  • Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).

Sites / Locations

  • Gunnel PetersonRecruiting
  • Gunnel PetersonRecruiting
  • Gunnel PetersonRecruiting
  • Gunnel PetersonRecruiting
  • Sofia AskRecruiting
  • Gunnel PetersonRecruiting
  • Emma Nilsing-StridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Implementation study - experimental group

Implementation study - control group

Arm Description

Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits

Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education.

Outcomes

Primary Outcome Measures

Implementation - Adoption of neck-specific exercise programmes
Proportion of patients with neck pain receiving neck-specific exercise
Patient Effectiveness - Neck Disability Index
Self-reported neck-specific function

Secondary Outcome Measures

Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)
Physiotherapists attitudes to implementation of evidence-based practice
Implementation - Practitioner Confidence Scale (PCS)
Self-efficacy and confidence to diagnose and treat patients with neck pain
Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week)
Numeric Rating Scale (NRS); 0=no pain or dizziness, 10=worst imaginable pain or dizziness).
Patient - rating of self-perceived health
How is your current health in general? Numeric Rating Scale 0-10, 0=the worst health; 10= "the best health you can imagine
Patient - Workability
Self-reported workability measured with the Work Ability Score (WAS). The worker's self-assessment of his/her current ability to work compared to the lifetime best.WAS; (0 = currently can not work at all, 10=work ability at it's best
Patient - The patient's assessment of perceived anxiety and depression
During the last week, have you felt anxious or depressed? Numeric Rating Scale (0-10), 0=no, not at all; 10= yes, very much
Patient - Improvement or deterioration over time
Global Rating scale (GRS) (-5=vastly worse, 0=unchanged, 5=completely recovered)

Full Information

First Posted
January 4, 2022
Last Updated
April 12, 2023
Sponsor
Sormland County Council, Sweden
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT05198258
Brief Title
Implementation and Evaluation of Neck-specific Exercises
Official Title
Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sormland County Council, Sweden
Collaborators
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Persistent pain and disability in whiplash-associated disorders (WAD) grade II and III are common. Randomized controlled studies (RCTs) have shown promising result for neck-specific exercise (NSE) programmes in chronic WAD with clinically and statistically significant improvement in pain and disability. Neck-specific exercise with internet support (NSEIT) and four visits to a physiotherapist was non-inferior to NSE at a physiotherapist clinic 2 times a week in 12 weeks (24 visits). The aims of the proposed study are to evaluate an implementation strategy for NSE and NSEIT in primary health care and to evaluate the effectiveness of NSE and NSEIT in clinical practice.
Detailed Description
The study is a prospective cluster-randomized study with hybrid II trial design. In total will 20 physiotherapy clinics in primary health care be recruited. Reg. physiotherapists working in the twenty physiotherapy clinics will be included. The clinics will be randomised to two groups with different implementation strategy: (A, intervention) three theoretical on-line lectures and the three hours' practical training with additional support; (B, control) the same education and practical training as A but with no additional support. Twenty-five patients with neck pain will be consecutively recruited from each clinic, a total of 500 patients. Outcome measurements will be conducted at baseline, 3- and 12-months. This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, also measuring diffusion of the method to other neck pain patients. In parallel, effectiveness of the exercises are evaluated. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. The implementation strategy will be analyzed using parametric t-test and a linear mixed model Analysis of Variance (ANOVA) or non-parametric Mann-Whitney U test and Kruskal-Wallis to evaluate differences between group A and B and change in variables over time. To further evaluate the implementation strategy will two focus group studies be conducted, with a purposeful sample of physiotherapists included in the cluster-randomized mixed-design study. The overall aim of these qualitative studies is to deepen the knowledge on the uptake of the new method, i.e., the NSEIT/NSE programme (adoption), the implementation in clinical practice (implementation), and how it continues to be used (maintenance). The effectiveness of NSEIT and NSE will be analysed with a linear mixed model Analysis of Variance (ANOVA) or Kruskal-Wallis depending on the data. The effect of neck-specific exercises in the present study will also be evaluated and compared to the results in our former RCT-studies. Sample size and power regarding group differences were calculated by a statistician. Sample size calculation was based on the assumption that 15% more patients will receive neck-specific exercises in the intervention group (40% in the intervention group and 25% in the control group). The required sample size under individual randomization will be 150 patients in each arm. With ten physiotherapy clinics (clusters) in each arm (a total of 20 clusters), intra-cluster correlation of 0.02 and a cluster size of 21 patients, a total of 420 patients are recruited for 80% power and a significance level of 0.05. To ensure that enough people are in each group after dropouts, a total of 500 patients will be included, 25 patients from each cluster. The patients will be consecutively recruited. Patients who are included in both the intervention and control groups and received neck-specific exercises will be treated as one group in terms of the effect of the intervention. The sample size calculation to evaluate effectiveness was based on a clinically relevant improvement of 7% on the Neck Disability Index (NDI), effect size 0.2 (Cohen's f) or 0.4 (Cohen's d), and correlation among repeated measures of 0.3, resulting in a total of 56 participants for 80% power and a significance level of 0.05. With an expected dropout rate of 20%, a total of 70 participating patients are needed. The patients will be analysed as one group and the total number of patients may be more than 70 because patients will be included at each clinic. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. Data will be analysed according to intention to treat and supplemented with per protocol analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Whiplash Injuries, Neck Disorder
Keywords
Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective cluster-randomized mixed-design study with hybrid II trial design. Twenty physiotherapy clinics in primary health care will be included.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation study - experimental group
Arm Type
Experimental
Arm Description
Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits
Arm Title
Implementation study - control group
Arm Type
Active Comparator
Arm Description
Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education.
Intervention Type
Other
Intervention Name(s)
Implementation strategy - experimental group
Intervention Description
On-line theoretical education and three hours of practical training by the project leaders. Contact with the project team via e-mail, phone and on-line repetition of the education for remaining of the clinical examination, neck-specific program and the progression of exercises.
Intervention Type
Other
Intervention Name(s)
Implementation - control group
Intervention Description
Physiotherapists in the control group will receive the same theoretical and practical training as the experimental group but without repetition of the education or support from the research team.
Primary Outcome Measure Information:
Title
Implementation - Adoption of neck-specific exercise programmes
Description
Proportion of patients with neck pain receiving neck-specific exercise
Time Frame
Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)
Title
Patient Effectiveness - Neck Disability Index
Description
Self-reported neck-specific function
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Secondary Outcome Measure Information:
Title
Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)
Description
Physiotherapists attitudes to implementation of evidence-based practice
Time Frame
Baseline
Title
Implementation - Practitioner Confidence Scale (PCS)
Description
Self-efficacy and confidence to diagnose and treat patients with neck pain
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Title
Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week)
Description
Numeric Rating Scale (NRS); 0=no pain or dizziness, 10=worst imaginable pain or dizziness).
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Title
Patient - rating of self-perceived health
Description
How is your current health in general? Numeric Rating Scale 0-10, 0=the worst health; 10= "the best health you can imagine
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Title
Patient - Workability
Description
Self-reported workability measured with the Work Ability Score (WAS). The worker's self-assessment of his/her current ability to work compared to the lifetime best.WAS; (0 = currently can not work at all, 10=work ability at it's best
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Title
Patient - The patient's assessment of perceived anxiety and depression
Description
During the last week, have you felt anxious or depressed? Numeric Rating Scale (0-10), 0=no, not at all; 10= yes, very much
Time Frame
Change from baseline to 3 months (after treatment) and 12 months follow-up
Title
Patient - Improvement or deterioration over time
Description
Global Rating scale (GRS) (-5=vastly worse, 0=unchanged, 5=completely recovered)
Time Frame
Measured at 3 months and 15 months follow up
Other Pre-specified Outcome Measures:
Title
Background data
Description
Background data from physiotherapists and patients such as age and gender
Time Frame
Baseline
Title
Implementation Qualitative data
Description
Two focus group studies with a purposeful sample of physiotherapists
Time Frame
After 2 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria implementation - Reg. physiotherapists working in twenty physiotherapy clinics in primary health care. Exclusion criteria implementation - No exclusion criterta Inclusion criteria to evaluate the effectiveness of neck-specific exercise The physiotherapists will include patients ≥ 18 years with neck pain. Patients are required to have internet access by phone, tablet, or computer Be able to read and understand Swedish Exclusion criteria: Physiotherapists should exclude patients with "red flags"i.e., symptoms that suggest a serious illness or spinal abnormality. Serious trauma to the neck and no X-ray Preceding neck surgery Osteoporosis Myelopathy History of cancer Unexplained weight loss Present fever, history of infections Constant and progressive non-mechanical pain Insidious progression of pain Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gunnel Peterson
Phone
+46722100901
Email
gunnel.peterson@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Organizational Affiliation
Centre for Clinical Research Sörmland, Uppsala University, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anneli Peolsson
Organizational Affiliation
Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emma Nilsing-Strid
Organizational Affiliation
University Health Care Research Center, Faculty of Medicine and Health, Örebro University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Siw Carlfjord
Organizational Affiliation
Department of Health, Medicine and Caring Sciences, unit of Physiotherapy, Linköping University
Official's Role
Study Chair
Facility Information:
Facility Name
Gunnel Peterson
City
Leksand
State/Province
Dalarna
ZIP/Postal Code
SE-581 83
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se
First Name & Middle Initial & Last Name & Degree
Sofia Ask
Email
sofia.ask@regionvastmanland.se
Facility Name
Gunnel Peterson
City
Ljusdal
State/Province
Gävleborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se
First Name & Middle Initial & Last Name & Degree
Sofia Ask
Email
sofia.ask@regionvastmanland.se
Facility Name
Gunnel Peterson
City
Helsingborg
State/Province
Skåne
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Phone
+46722100901
Email
gunnel.peterson@liu.se
First Name & Middle Initial & Last Name & Degree
Anneli Peolsson
Email
anneli.peolsson@liu.se
Facility Name
Gunnel Peterson
City
Nyköping
State/Province
Sörmland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se
First Name & Middle Initial & Last Name & Degree
Sofia Ask
Email
sofia.ask@regionvastmanland.se
Facility Name
Sofia Ask
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
SE-581 83
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Ask
Phone
+46722100901
Email
sofia@regionvastmanland.se
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se
Facility Name
Gunnel Peterson
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se
First Name & Middle Initial & Last Name & Degree
Jesper Hävermark
Email
jesper.havermark@regionuppsala.se
Facility Name
Emma Nilsing-Strid
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Nilsing-Strid
Email
emma.nilsing-strid@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Gunnel Peterson
Email
gunnel.peterson@liu.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
35637458
Citation
Peterson G, Carlfjord S, Nilsing Strid E, Ask S, Jonsson M, Peolsson A. Evaluation of implementation and effectiveness of neck-specific exercise for persistent disability and pain after whiplash injury: study protocol for a randomized controlled study using a hybrid 2 design. BMC Musculoskelet Disord. 2022 May 30;23(1):516. doi: 10.1186/s12891-022-05470-y.
Results Reference
derived

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Implementation and Evaluation of Neck-specific Exercises

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